Lindsey

5 Tricks that reduce low volume supplier lead times

reduce low volume lead timesNegotiating low volume lead supplier times is not without challenges. Vendors can look at low volume quantities or lower dollar value orders as less priority or of importance to fulfill.  Adding to this challenge, Just In Time (JIT) delivery is often used to meet on demand client sales orders.
The pre-planned anticipated lead time in your ERP (Enterprise Resource Planning) system must be correct with no room for error. A caveat being early delivery. This is usually welcomed without penalty to supply chain.

Continue reading »

Vanessa Del Castillo Faria

How to extract good value from your medical device supply chain

extract good value from your medical device supply chain
Manufacturing low volume, high complex medical device products requires sourcing highly customized and expensive parts. This makes it hard to extract good value from your medical device supply chain.
While high-volume production enables economies of scale, low volume custom-made production involves fewer parts to absorb product development, tooling and production equipment costs.

Continue reading »

Dana Trousil

First-to-Market Vs. robust commercialization: trade-offs, tips, and tactics

First-to-Market Vs. robust commercialization
Bringing your medical device to market involves a lot of trade-offs. First-to-Market Vs. robust commercialization process. Do you launch quickly with a minimum viable product? There may be significant post-launch changes in order to be the first to market.
Possible negative feedback from rushing to market may destroy any device adoption. Perhaps going through an extra spin or two to resolve potential manufacturability or production issues is warranted. Below are some trade-offs, tips, and tactics from our manufacturing and supply chain team that are worth thinking about.

Continue reading »

Susan Bantroch

Consider these 3 areas carefully when testing medical devices in a Biolab

Testing Medical Devices in a BiolabKeep your project on time, within budget 

Testing medical devices in a Biolab often requires changing locations from an engineering lab to a Biosecurity Level 2 (BSL2) BioLab that can facilitate specialized tests involving potentially dangerous microorganisms, tissues and biological fluids. Careful pre-planning is required for timely experiments to take place in BSL2 BioLabs. Poorly designed devices or tests can delay obtaining critical results, and create unnecessarily large bills.

Continue reading »

Alexandra Reid

Bringing Consistency to the FDA’s Inspection Process

Leveling the Playing Field with recent Draft Guidance

 

FDA’s Inspection ProcessReview and Update of Device Establishment Inspection Processes and Standards, a draft guidance document from the FDA, establishes uniform processes and standards for FDA’s Inspection Process of both domestic and foreign medical device firms. The FDA’s plan is outlined in a short, six-page document released March 29, 2019. The goal is to bring more consistency to the inspection process.

Continue reading »

Hannah Rusak-Gillrie

How to turn patient imaging data into functional 3D models

functional 3D modelsPatient imaging data is a powerful and robust source for developing anatomically accurate and functional 3D models. Having an accurate representation of anatomy available to engineers and designers during product brainstorming and design is an invaluable resource. This blog outlines the process of creating 3D models, and innovative methods to use them throughout medical device development.

Continue reading »

Luke Mills

Maximizing Efficiency in a Switch Mode Power Supply

Switch Mode Power SupplyWhy spend time maximizing efficiency in a switch mode power supply? Higher efficiency switching regulators get you more bang out of your buck. In a world of mobile devices, minimizing power consumption is a must. Don’t waste power in the power supply. This blog looks at the sources of inefficiency one would find in a typical buck or boost style DC-DC converter.

Continue reading »